Dry powder inhaler

ABSTRACT

An inhalation device for the uptake of medicaments that are in the form of dry powder contained in the blisters of specially designed single dose blister strips. The device is comprised of a mouthpiece (A), a strip support surface area (B). and one or more storage areas (C). Furthermore, the single dose blister strip is described. It is comprised of two sheets (17, 20) that are fixed in such a manner so that when they get separated the powder becomes available for inhalation.

BACKGROUND OF THE INVENTION

The present invention refers to an inhaler for the uptake of medicamentsin the form of dry powder and to specialty designed single dose blisterstrips that are used with the said inhaler.

FIELD OF THE INVENTION

The inhaling devices currently used can be separated into twocategories:

1. Those where the pharmaceutical powder is stored in a container out ofwhich a measured amount of powder can be released via specificmechanisms. EP0069715 for example, describes a device in which thepowder is metered in given dosages through apertures located in arotatable disc, these apertures being introduced into an airduct orchannel through which air is inhaled, by rotating the disc.

DESCRIPTION OF PRIOR ART

2. Those where measured amounts of pharmaceutical powder can be storedseparately in special containers. GB2242134 for example, describes adevice which uses a flexible strip defining a plurality of pockets eachof which contains a dose of medicament which can be inhaled. The devicecontains a chamber in which the strip is housed, an opening stationwhich contains means for peeling the two sheets or the strip apart andan outlet through which the user can inhale the medicament.

The major disadvantages of these and other similar devices are that a.the user cannot visually verify whether he has received the entire doseof the medicament, and b. they function through complicated internalmechanisms.

SUMMARY OF THE INVENTION

The advantage of the present invention is that the user can visuallycheck the presence of the medicament in the blister of the strip priorto inhalation and verify after the inhalation that he has received theentire dose of the medicament. Additionally, the device is simple tomanufacture and easy to operate.

The device of the present invention is comprised of three parts: themouthpiece, through which the powder is inhaled, the blister stripsupport surface and the strip storage compartment(s), which house(s) alarge number of blister strips. The three parts are connected to eachother and can be independently opened. The support surface contains anattachment point, where the blister strip is attached with the help ofan attachment formation; a cavity, which accommodates the blister of thestrip; and strip guides, which secure the proper and firm placement ofthe strip on the surface. The single dose blister strip is comprised oftwo sheets that can be pealed away from each other. The base sheet has ablister which contains the powder, and an attachment formation whichfits to the attachment point of the support surface. The cover sheetseals the base sheet only in the area around the blister. The principleof use is that the user securely attaches the blister strip on theattachment surface, pulls away the cover sheet of the blister byexercising a slight force, checks the content of the blister, inhalesthe medicament, and finally verifies that he has received the entiredose.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-9 depict examples of the invention.

FIG. 1 shows different views of an example of an inhaler.

FIG. 2 shows the mouthpiece of the device along with its componentparts.

FIG. 3 shows the part of the device that contains the area on which theblisters are placed.

FIG. 4 shows the blister storage compartment.

FIG. 5 shows a single dose blister strip and the way it is put together.

FIG. 6 shows the process that reveals the powder in the blister.

FIG. 7 shows the flow of air and powder during the inhalation process.

FIGS. 8 and 9 are further examples of inhalers based on the principle ofthe present invention.

DETAILED DESCRIPTION OF THE INVENTION

The inhaler (FIG. 1) includes 3 basic parts, the mouthpiece A with itscover, part B with the surface on which the blister strip is placed, andthe blister strip storage part C. The parts are connected to each otherand can be opened independently.

The mouthpiece (FIG. 2) is comprised of parts 1, 2 and 3. Part 1 locksin part 2 and part 2 locks in part 3.

Part 1 is the external part of the mouthpiece, and may have air openingsat its base.

Part 2 is a cylinder with a wider base. The top of the cylinder has anopening 4, which serves as the exit of the powder from the device.Inside the cylinder there is formation 5, which may be of helical orother shape, through which the inhaled powder containing air exits thedevice. The end of formation 5 at the base of part 2 is blocked in halfwith surface 6.

Part 3 is also a cylinder, which has a wider top. The interior of part 3is divided into in chambers 7 and 8, by an upright flat divider surface9. The base of part 3 touches the blister. It has two holes, 10 and 11,one on each side of divider 9. Hole 11 may contain a sieve, in order toblack the passage of larger particles. Chamber 7 contains hole 10, andis blocked at its top with surface 6. Furthermore, chamber 7 containshole 12, which serves as the air entrance.

The single dose blister strip is placed on the attachment surface ofpart B (FIG. 3). This surface has a protrusion 13 that serves as theattachment point, a cavity 14 which receives the blister of the strip,and a system of strip guides, 15 and 16 in the specific example. Theprotrusion, the cavity and the guides enable the correct alignment ofthe strip on the surface of part B and secure its firm placement duringthe use of the device. The lower portion of part B can be used as astorage compartment for the blister strips.

The strip storage part C (FIG. 4) can be of various shapes, and maycontain a grid, depending on the number of strips it accommodates, e.g.30 or 60.

The blister strip (FIG. 5) consists of two sheets (FIG. 5A) made ofsuitable material e.g. PVC, aluminium, polyamide, paper, polyester,vinyl gum. One of the two sheets is the base sheet 17, which has theblister 18 that contains the powder, and the attachment hole 19. Theother is the cover sheet 20 that is fixed to the base sheet, e.g. byheat adhesion, and air-tightly seals only the area around blister 18, asshown in the drawing (FIG. 5B, darkened area). Sheet 20 is then foldedby a 180-degree rotation around axis DE, revealing hole 19 and coveringthe flat surface of blister 18 (FIG. 5C).

The process by which the blister-contained powder is exposed takes placein two stages (FIG. 6).

During the first stage FIG. 6A) and while the mouthpiece is open, theuser secures the strip on the support surface of part B by placing hole19 around protrusion 13. Blister 18 is then placed in cavity 14 with theassistance of guides 15 and 16. During the second stage (FIG. 6B), theuser closes the mouthpiece and pulls cover sheet 20 towards thedirection of the arrow until it is completely detached.

At this point and after lifting the mouthpiece, the user can verify thatthe powder contained in blister 18 has been revealed and is availablefor inhalation (FIG. 6C). The user then just closes the mouthpiece andinhales. Finally, by opening again the mouthpiece, he can visually checkwhether he has inhaled the medicament.

During the process of inhalation (FIG. 7) the air that is breathed-inenters the mouthpiece via the air openings, and then enters chamber 7through hole 12. From there on and passing through hole 10, the aircarries along the powder which is located in blister 18 and passingthrough hole 11 brings it to chamber 8. From there and through formation5, the powder exits the device.

Another example of the invention is shown in FIG. 8. The attachmentpoint for the blister strip on surface B is cavity 21. The mouthpiece Acontains projection 22 which, when said mouthpiece is closed, enterscavity 21 and in this way secures the blister. In this case, the blisteris placed on surface B with hole 19 above cavity 21. Alternatively,blister strip hole 19 could be replaced by a cavity.

FIG. 9 shows another embodiment of the invention. In this case, theattaching component of the blister strip is formation 23 that is placedin the openings 24 of guides 15 and 16 of surface B.

It is obvious that there may be variations relating to the shape and thepositions of the attachment point, the cavity and the guides on surfaceB, which can achieve appropriate and secure attachment of the blister.All these different embodiments are also included in the scope of thepresent invention.

A further embodiment of the inhaler would include its use through thenose. This could be achieved by substituting the mouthpiece with theappropriate attachment.

1. A device for the inhalation of medicaments in the form of dry powderstored in single dose blister strips comprising a base sheet and a coversheets, which device includes a mouthpiece through which the powder isinhaled, a part with a blister strip support surface wherein saidsurface includes a cavity which accommodates the blister and a stripstorage compartment wherein the blister strip support surface furtherincludes an attachment point and strip guides and wherein the mouthpieceis openably connected to said part comprising the blister strip supportsurface; and wherein the cavity and guides are located such thatexposure of the powder may be effected by pulling away the cover sheetfrom the base sheet in a direction which lies in a plane perpendicularto the attachment point and directly away from said attachment point. 2.A device according to claim 1, wherein the mouthpiece is comprised ofthree parts whereby the first part locks in the second part and thesecond part locks in the third part, said first part being an externalpart of the mouthpiece, said second part being a cylinder with a widerbase, whose top serves as an exit of the powder from the device andwhose base locks to the top of the third part, said third part being acylinder with a wider top which contains a side hole as air entrance andwhose base contains two holes which touch the blister when a blisterstrip is inserted into the device.
 3. An inhalation device according toclaim 2, wherein the second part comprises a base portion and containswithin it a helical formation whose end at the base of said part isblocked in half by a surface; wherein the third part is divided in twochambers by an upright flat surface and wherein the top of the chamberwhich contains the air entrance hole is blocked by a surface.
 4. Adevice according to claim 3, wherein the single dose blister strip iscomprised of a base sheet which defines a blister that contains thepowder and an attachment formation and a cover sheet which isair-tightly sealed to the base sheet in the area around the blister (18)and can be detached from the base sheet.
 5. An inhalation deviceaccording to claim 2, wherein the attachment point is adapted tocooperate with an attachment formation on said blister strip which is inthe form of a hole.
 6. A device according to claim 2 wherein themouthpiece contains a projection.
 7. A device according to claim 2,wherein the attachment point is a protrusion.
 8. A device according toclaim 2, wherein the single dose blister strip is comprised of a basesheet which defines a blister that contains the powder and an attachmentformation and a cover sheet which is air-tightly sealed to the basesheet in the area around the blister and can be detached from the basesheet.
 9. A device according to claim 1, wherein the mouthpiece containsa projection.
 10. A device according to claim 9, wherein the single doseblister strip is comprised of a base sheet which defines a blister thatcontains the powder and an attachment formation and a cover sheet whichis air-tightly sealed to the base sheet in the area around the blisterand can be detached from the base sheet.
 11. A device according to claim1, wherein the attachment point is a protrusion.
 12. An inhalationdevice according to claim 1, wherein the single dose blister strip iscomprised of a base sheet which defines a blister that contains thepowder and an attachment formation and a cover sheet which isair-tightly sealed to the base sheet in the area around the blister andcan be detached from the base sheet.